School-based Treatment of Anxiety Research Study (STARS)

Not Applicable

Completed

• Conditions: Anxiety Disorders
• Interventions: Behavioral: UC; Behavioral: CBT

• Registration Number: NCT01761396
• Lead Sponsor: UConn Health

Brief Summary

This research is being done to compare two types of talk therapy to see which is most effective in helping school children with anxiety disorders. The investigators will compare usual care (UC) with cognitive behavioral therapy (CBT). Both therapies will be administered by the school mental health counselors to see if they help children with anxiety disorders to feel less scared or worried.

Detailed Description

This four year study involves a blocked randomized controlled trial (RCT) comparing the effectiveness of school-based CBT to usual care (UC) for approximately 375 students ages 7-17 diagnosed with an anxiety disorder. Randomization will occur at the school level and the investigators propose to conduct the study in approximately 46 schools (23 in CBT; 23 UC). Evaluations will be conducted by study staff to measure treatment progress at the end of the 12-week treatment program, at a three month follows up, and at natural termination.

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-10-12
• Study First Submitted QC: 2013-01-03
• Study First Posted: 2013-01-04
• Primary Completion: 2018-05-01
• Study Completion: 2018-06-30
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-07
• Last Update Posted: 2019-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 216

Inclusion Criteria

• between the ages of 6-18 inclusively
• meet DSM-IV criteria for a primary anxiety disorder

Exclusion Criteria

• presence of a medical or psychiatric condition contraindicating study treatment (e.g., suicidal intent)
• need more immediate or alternative treatment
• receiving psychosocial treatment for anxiety
• victim of previously undisclosed child abuse and require ongoing Department of Children and Families (DCF) supervision

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
UC	UC	Usual care
CBT	CBT	Cognitive behavioral therapy

Primary Outcome Measures

Name	Time	Method
Clinical Global Impressions Improvement Scale	12 weeks post-treatment	Improvement in Clinical Anxiety Diagnosis

Secondary Outcome Measures

Name	Time	Method
School Records	12 weeks post-treatment	Academic functioning
Teacher Report Form	12 weeks post-treatment	classroom behavior and performance

Trial Locations

Locations (1)

University of Connecticut Health Center; 🇺🇸 Farmington, Connecticut, United States